R2 Dermabrasion Tip (for Dermal Cooling System)

K203006 · R2 Technologies, Inc. · QPZ · Aug 5, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K203006
• Device Name: R2 Dermabrasion Tip (for Dermal Cooling System)
• Applicant: R2 Technologies, Inc.
• Product Code: QPZ · General, Plastic Surgery
• Decision Date: Aug 5, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4340
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal. The Dermal Cooling System is intended to be used by trained healthcare professionals.

Device Story

Dermal Cooling System is a cryosurgical device for skin cooling without cryogenic gases/liquids. Uses thermoelectric cooler (TEC) with integrated aluminum plate to lower skin temperature. Handpiece serves as handle for manual R2 Dermabrasion Tips. Used by trained healthcare professionals in clinical settings. Dermabrasion tips facilitate manual dermabrasion for scar/tattoo removal. Cooling effect provides pain/swelling relief post-procedure. Healthcare providers use device to perform aesthetic skin treatments and manage post-surgical symptoms. Benefits include non-invasive lesion removal and temporary pain/inflammation reduction.

Clinical Evidence

No clinical data. Bench testing only. Dermabrasion performance test (n=3) and thermal insulation test (n=3) conducted to validate accessory safety and effectiveness. Results showed no unexpected side effects and skin temperature maintained at or above +20 °C.

Technological Characteristics

Thermoelectric cooler (TEC) with integrated aluminum plate for surface contact cooling. Manual dermabrasion tips fabricated from metal with textured surface. Standalone device. No cryogenic gases or liquids used.

Indications for Use

Indicated for dermatologic procedures to remove benign skin lesions and for cooling to reduce pain, swelling, inflammation, and hematoma from minor surgical procedures. When used with R2 Dermabrasion Tips, indicated for general dermabrasion, scar revision, acne scar revision, and tattoo removal. For use by trained healthcare professionals.

Regulatory Classification

Identification

A contact cooling system for aesthetic use is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption of adipocyte cells intended for non-invasive aesthetic use.

Special Controls

*Classification.* Class II (special controls). The special controls for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Dermal Cooling System (K201260)

Reference Devices

• Derma Paddle (Livra) attachment (Procell Therapies)

Submission Summary (Full Text)

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August 5, 2021

R2 Technologies, Inc. Ragan Reppond Sr. Director, HR & Corporate Affairs 2603 Camino Ramon. Suite 200 San Ramon, California 94583

Re: K203006

Trade/Device Name: Dermal Cooling System Regulation Number: 21 CFR 878. 4340 Regulation Name: Contact Cooling System for Aesthetic Use Regulatory Class: Class II Product Code: QPZ, GED Dated: June 9, 2021 Received: June 11,2021

Dear Ragan Reppond:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdth/cfdocs/cfpmn/pmn.cfm identifies coombination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Leam (https://www.fda.gov/training-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K203006

Device Name Dermal Cooling System

#### Indications for Use (Describe)

The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.

When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal.

The Dermal Cooling System is intended to be used by trained healthcare professionals.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# K203006

## 510(k) Summary

- I. SUBMITTER R2 Technologies, Inc. 2603 Camino Ramon, Suite 200 Bishop Ranch 3 San Ramon, CA 94583
- Contact: Ms. Ragan Reppond Vice President of Corporate Affairs & Compliance R2 Technologies, Inc. Phone: [phone]

[e-mail]

Date Prepared: July 29, 2021

#### II. SUBJECT DEVICE and ACCESSORY

| Device Name: | Dermal Cooling System |
|------------------------|---------------------------------------------|
| Device Common Name: | Contact cooling for skin lesion pain relief |
| Accessory Name: | R2 Dermabrasion Tips |
| Accessory Common Name: | Brush, Dermabrasion, Manual |
| Regulatory Class : | II |
| Product Code : | QPZ, GED |
| Regulation : | 21 CFR 878.4340, 21 CFR 878.4800 |

#### III. PREDICATE AND REFERENCE DEVICES

The predicate device is the Dermal Cooling System, K201260.

| Name of Device: | Dermal Cooling System |
|-------------------|-----------------------------------|
| Common Name: | Cryosurgical unit and accessories |
| Regulatory Class: | II |
| Product Code: | GEH, MLY |
| Regulation: | 21 CFR 878.4350 |

The reference device is the Derma Paddle (Livra) attachment (Class I, 510(k) exempt), manufactured by Procell Therapies.

#### IV. DEVICE DESCRIPTION

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# K203006

The Dermal Cooling System is identical to the device cleared in K201260. The Dermal Cooling System is a cryosurgical device used to cool the skin, without the use of cryogenic gases or liquids, for the removal of benign skin lesions and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lowerthe temperature of the skin. For dermabrasion, the Dermal Cooling System handpiece is intended to serve as a handle to facilitate manual movement of the R2 Dermabrasion Tips.

The R2 Dermabrasion Tips are optional accessories for the Dermal Cooling System that may be attached to the distal end of the handpiece to facilitate manual dermabrasion. The R2 Dermabrasion Tips may be used with a commercially available topical or water to facilitate movement of the handpiece across the treatment area.

### V. INDICATIONS FOR USE

The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.

When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal.

The Dermal Cooling System is intended to be used by trained healthcare professionals.

## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE

The predicate device, the Dermal Cooling System, has not been modified for use with the R2 Dermabrasion Tips and proposed expanded indication, i.e., general dermabrasion, scar revision, acne scar revision, and tattoo removal.

The reference device, the Derma Paddle (Livra) attachment, is included to substantiate the proposed expanded indications for use for the R2 Dermabrasion Tips as the intended use for the Derma Paddle (Livra) attachment (510(k) exempt) includes "general dermabrasion, scar revision, acne scar revision, and tattoo removal". The R2 Dermabrasion Tips and the Derma Paddle (Livra) attachment have these same fundamental scientific technological elements:

The R2 Dermabrasion Tips and the reference device, Derma Paddle (Livra) attachment have these similarities:

- used for aesthetic purposes;
- fabricated from metal; ●

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- textured surface (roughness);
- intended for manual dermabrasion;
- classification (generic description)

The key differences between the R2 Dermabrasion Tips and the Derma Paddle (Livra) attachment are:

- geometry
- mechanism of attachment

The differences do not raise new questions of safety and effectiveness with respect to the R2 Dermabrasion Tips and proposed expanded indication.

### VII. PERFORMANCE DATA

Performance data is provided in support of the substantial equivalence determination, as summarized in the table below.

Dermabrasion performance test demonstrated the R2 Dermabrasion Tips can perform its intended use safely and effectively when used with the Dermal Cooling System, while the thermal insulation test supported the conclusion no additional risk was introduced when the R2 Dermabrasion Tips are used with the Dermal Cooling System.

| Test | Test method/Requirement | Acceptance criteria | Results |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------|
| Accessories<br>Validation | Dermabrasion Performance Test:<br>3 subjects tested with the R2<br>Dermabrasion Tips (20 Amps<br>EDM) and 3 subjects tested with<br>(80 Amps EDM) | No unexpected side effects<br>observed immediately post test,<br>and 2-days post test | Passed |
| | Thermal Insulation Test:<br>3 subjects tested with the R2<br>Dermabrasion Tips (20 Amps<br>EDM and 80 Amps EDM) | Skin temperature to remain at or<br>above +20 °C for the full duration | Passed |

No preclinical or clinical testing was performed.

### VIII. CONCLUSIONS

An optional accessory, manual dermabrasion tips, is added to the Dermal Cooling System cleared in K201260. Performance tests demonstrated the dermabrasion tips can perform as intended when used with the Dermal Cooling System without introducing additional risks for the intended use. No new question of safety or effectiveness is raised. The subject device is therefore considered as substantially equivalent to the predicate device K201260.